Trial record 1 of 1 for:    NCT00531661
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CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CardioMEMS
ClinicalTrials.gov Identifier:
NCT00531661
First received: September 18, 2007
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.


Condition Intervention
Heart Failure, Congestive
Device: HF Pressure Measurement System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by CardioMEMS:

Primary Outcome Measures:
  • Rate of Heart Failure Related (HFR) Hospitalizations [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Freedom From a Device/System-related Complication (DSRC). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:

    • is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes)
    • results in the death of the subject
    • results in the explant of the device

  • Freedom From Pressure Sensor Failure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.


Secondary Outcome Measures:
  • Change From Baseline in Pulmonary Artery Mean Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.

  • Proportion of Patients Hospitalized for Heart Failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Days Alive Outside of the Hospital [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.


Other Outcome Measures:
  • Rate of HFR Hospitalizations [ Time Frame: Study duration: average patient follow-up of 15 months ] [ Designated as safety issue: No ]
  • Freedom From a Device/System-related Complication (DSRC) [ Time Frame: Study duration: average patient follow-up of 15 months ] [ Designated as safety issue: Yes ]
  • Freedom From Pressure Sensor Failure [ Time Frame: Study duration: average patient follow-up of 15 months ] [ Designated as safety issue: Yes ]

Enrollment: 550
Study Start Date: September 2007
Estimated Study Completion Date: October 2014
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TREATMENT Group
Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
Device: HF Pressure Measurement System
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
Placebo Comparator: CONTROL Group
Standard of care HF management

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF
  2. Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
  3. Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.
  4. At least 1 HF hospitalization within 12 months of Screening Visit
  5. Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)

Exclusion Criteria:

  1. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
  2. Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization
  3. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit
  4. Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment
  5. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis
  6. Subjects likely to undergo heart transplantation within 6 months of Screening Visit
  7. Subjects with congenital heart disease or mechanical right heart valve(s)
  8. Subjects with known coagulation disorders
  9. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531661

Locations
United States, Georgia
CardioMEMS Investigational Sites
Nationwide, Georgia, United States, 30313
Sponsors and Collaborators
CardioMEMS
Investigators
Principal Investigator: Phillip Adamson, MD, FACC Oklahoma Heart Hospital
Principal Investigator: William T Abraham, MD, FACC Ohio State University
  More Information

No publications provided

Responsible Party: CardioMEMS
ClinicalTrials.gov Identifier: NCT00531661     History of Changes
Other Study ID Numbers: CM-06-04
Study First Received: September 18, 2007
Results First Received: November 16, 2012
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014